drugset / Trial / NCT03027193
A Study to Determine the Safety and Immunogenicity of a Candidate MAP Vaccines ChAdOx2 HAV and MVA in Healthy Adult Volunteers
Non-randomizedParallel-groupOpen-labelTreatment
Summary
A phase I dose escalation study to assess the safety and immunogenicity of the candidate vaccines ChAdOx2 HAV and MVA HAV in healthy volunteers. Volunteers will be recruited and vaccinated in Oxford, England. All vaccinations will be administered intramuscularly. Three different doses of the ChAdOx2 HAV will be tested (5x10\^9 vp, 2.5x10\^10 vp and 5x10\^10vp). MVA HAV will be assessed at 2 different doses (5x10\^7 and 2x10\^8 pfu) The total duration of the study will be 52 weeks from the day of enrolment for volunteers receiving ChAdOx2 HAV only, 12 weeks for volunteers receiving MVA HAV only and 20 weeks for volunteers receiving ChAdOx2 HAV and MVA HAV.
Timeline
- Start
- 2017-03-15
- Primary completion
- 2020-01-16
- Completion
- 2020-01-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ChAdOx2 HAV | Vaccine | 5e+09 unknown | Intramuscular |
| Subject | ChAdOx2 HAV | Vaccine | 2.5e+10 unknown | Intramuscular |
| Subject | ChAdOx2 HAV | Vaccine | 5e+10 unknown | Intramuscular |
| Subject | MVA HAV | Vaccine | 5e+07 unknown | Intramuscular |
| Subject | MVA HAV | Vaccine | 2e+08 unknown | Intramuscular |